Many Americans have been following the implementation and enforcement of new state laws and new interpretations of existing laws governing abortion since the Supreme Court, in Dobbs v. Jackson Women’s Health Organization, overturned its longstanding precedents on abortion on June 24, 2022. Recently, public attention has focused on state court opinions that interpret and apply these abortion laws. In February, an Alabama Supreme Court decision declared that embryos created through in vitro fertilization (IVF) are children under the state’s wrongful death of a minor laws, even when the embryos remain frozen; and in April, an Arizona Supreme Court decision declared that an 1864 law criminalizing abortion is effective and enforceable. Both the Alabama and Arizona legislatures enacted new legislation in reaction to these decisions, but they leave unanswered questions about the scope of certain laws and potential liabilities.
Generally, embryonic stem cells used in research have been derived from embryos donated by individuals who have undergone IVF treatment. Most fertility providers require patients to make decisions about the future use of their embryos before freezing them, so that, in the event of a death, divorce, or other future event, the provider is able to comply with the patient’s wishes for the disposition of embryos. In some cases, patients are permitted to donate the unused embryos, which would often otherwise be discarded, for research purposes. In fact, all embryonic stem cells used to create the cell lines on the National Institute of Health Human Embryo Stem Cell Registry were created for reproductive purposes and donated with the patients’ informed consent. Guidance from the American Society for Reproductive Medicine also states that frozen embryos should only be used for research purposes with patients’ written informed consent. But state court activity, like the Alabama opinion described above and a petition pending before the Texas Supreme Court related to a couple’s dispute over their frozen embryos, may limit patients’ ability to donate their embryos for research purposes, and, therefore, the availability of embryonic stem cells for research. And other state laws may restrict the use of embryonic stem cells for research purposes in the state.
In addition, the Arizona Supreme Court’s decision indicates a willingness by some state courts to revisit longstanding but not previously enforced restrictions on abortion, and apply them to restrict drugs and medical procedures that did not exist at the time of the law’s enactment. Many states’ laws governing embryonic stem cell research were enacted in the late 1990’s and early 2000’s, and, therefore, pre-date many significant advances and new therapies that rely on embryonic stem cells and cell lines.
Some states, like Arizona, criminalize “destructive human embryonic stem cell research.” Others, like Michigan and Missouri, have amended their constitutions to permit research with embryonic stem cells, as long as it is conducted in accordance with specified limitations. Some states restrict the use of public facilities for research involving “the intentional destruction of a human embryo” (see, e.g., Kentucky) or the availability of tax credits for this research (see, e.g., Virginia). But few states have comprehensive regulatory schemes for the donation and subsequent use of embryonic stem cells and cell lines for research purposes.
Often, relevant state laws do not clearly define key terms, including “embryo.” These laws also do not distinguish among frozen embryos, embryonic stem cells, and cell lines derived from embryos years or decades ago. And many states do not address embryonic stem cell research at all. But, as noted above, state laws or court decisions that treat embryos, whether in vitro or in utero, as “children” or “persons” will effectively restrict, or potentially prohibit, the donation of embryos and the use of human embryonic stem cells for research, and may set up conflicts with other laws already in place in the applicable state.
Across the United States, the support for – and regulation of – research involving embryonic stem cells varies significantly. In the current climate, researchers should not assume that the lack of explicit restrictions means that this type of research is, or will continue to be, permitted. Researchers, manufacturers, and others in the industry should pay close attention not only to the laws on the books but also to new developments in state courts where they are considering or conducting research.
If you have any questions about the potential impact of state laws on research with embryonic stem cells or cell lines, please contact any of the authors of this alert or the Hogan Lovells lawyer with whom you regularly work.
Authored by Lindsey Johnson, Brooke Bumpers, and Beth Roberts
